Home / 510(k) Clearances / K232549

510(k) K232549

NemoCast by Software Nemotec S.L. — Product Code PNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2023
Date Received
August 23, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthodontic Software
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

Other clearances by Software Nemotec S.L.

  • K232698 — NemoScan (January 18, 2024)
  • K193003 — NemoCast (June 5, 2020)
  • K192475 — NemoFAB (April 23, 2020)
  • K192571 — NemoScan (December 11, 2019)

Other clearances for product code PNN

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  • K252507 — SmileInspector (January 7, 2026)
  • K253343 — Celebrace Software (December 29, 2025)
  • K250198 — Laon Ortho (April 23, 2025)
  • K241153 — Progressive Orthodontics App (October 11, 2024)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232564 — Align Studio (March 12, 2024)
  • K233616 — Clevaligner Software (V1.0.0) (January 11, 2024)
  • K232429 — Titan Dental Design (October 13, 2023)
  • K223518 — iOrtho (June 13, 2023)